Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial

老年急性 HFpEF 患者的身体康复 - REHAB-HFpEF 试验

• 批准号: 10501900
• 负责人: DALANE W KITZMAN
• 金额: $ 594.4万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10501900
• 关键词: Accident and Emergency department; Acute; Address; Affect; Age; Attention; Black Populations; Blood specimen; Caregivers; Cessation of life; Clinic Visits; Clinical; Cognition; Data; Dissemination and Implementation; EFRAC; Educational workshop; Elderly; Enrollment; Ensure; Event; Evidence based treatment; Funding; Future; Geography; Guidelines; Health Care Costs; Health system; Heart failure; Hospitalization; Impairment; Institutionalization; Intervention; Leadership; Medical; Medicare claim; Mental Depression; Morbidity - disease rate; Multicenter Trials; National Heart, Lung, and Blood Institute; Not Hispanic or Latino; Outcome; Participant; Pathway interactions; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Phenotype; Physical Function; Physical Performance; Physical Rehabilitation; Physical activity; Prevalence; Randomized; Recommendation; Reporting; Research Personnel; Resources; Structure; Subgroup; Syndrome; Testing; Time; Underserved Population; Vulnerable Populations; Walking; Woman; adjudicate; attentional control; clinical care; clinical center; cohesion; cost effectiveness; cost estimate; data repository; disability; experience; falls; follow-up; frailty; health care service utilization; health related quality of life; heart preservation; high risk; high risk population; hospital readmission; improved; innovation; intervention effect; intervention program; meter; mortality; multidisciplinary; novel; older patient; older women; phase II trial; physical conditioning; physically handicapped; preservation; primary endpoint; primary outcome; response; secondary endpoint; secondary outcome; single-blind trial; treatment as usual; trend

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons, and is associated with marked physical disability, poor health-related quality of life (HRQOL), frequent rehospitalizations, loss of independence, high mortality, and enormous health care costs. However, most of the trials testing a wide range of medications and strategies in ADHF have been neutral. In our recently completed NIA-funded phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of Short Physical Performance Battery (+1.5 points) in older patients with ADHF. At baseline, the participants (53%) with HF with preserved ejection fraction (HFpEF), had significantly worse impairments in physical function, frailty, HRQOL, and depression than those with HF with reduced EF. They also appeared to derive greater benefit from the intervention, with ~50% larger effect sizes in physical function, frailty, HRQOL, and depression. Patients with HFpEF also appeared to have much greater reductions in rehospitalizations and death and potential for reduced medical resource use. The finding of potentially greater benefit in HFpEF is noteworthy as HFpEF is highly relevant to older persons and has the most urgent need for new treatments since it is: 1) the most common form of HF, nearly unique to older persons, and disproportionately affects older women and Black persons; 2) increasing in prevalence; 3) accepted as a geriatric syndrome; 4) associated with marked impairments in physical function and HRQOL and high rates of frailty; 5) has high morbidity and mortality which are worsening over time; and 6) has limited evidence-based treatments. The phase 3 REHAB- HFpEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized, attention-controlled, single-blinded trial will enroll 880 older adults age >60 years with ADHF and HFpEF across 20 geographically dispersed clinical centers. We will test the hypothesis that the innovative REHAB-HF intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (Aim 1) and the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of older adults, at 6-months (Aim 2). We will also assess the intervention’s impact on HRQOL, frailty, depression, physical activity, and health care costs. Our diverse, cohesive, multi-disciplinary team and experience from the phase 2 trial will ensure efficient and effective execution and dissemination. REHAB-HFpEF directly addresses the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve key outcomes that are meaningful to patients, caregivers, health systems, and payers. The trial has strong potential to change clinical guidelines, reduce health care costs, and influence national coverage decisions for the large, growing, underserved, high-risk population of older patients with acute HFpEF.

急性失代偿性心力衰竭(ADHF)是老年人住院的主要原因， 与明显的身体残疾、与健康相关的生活质量(HRQOL)差有关，经常 再次住院、丧失独立性、高死亡率和巨大的医疗费用。然而，大多数 在ADHF中测试各种药物和策略的试验一直是中立的。在我们最近 完成了由NIA资助的第二阶段试验(Rehab-HF)，这是一项创新、早期、过渡性、量身定制和渐进式的试验 多领域物理康复干预对短暂性脑损伤的主要预后有较大改善 老年ADHF患者的体能电池(+1.5分)。在基线时，参与者(53%) 射血分数(HFpEF)保留的心衰患者的身体功能损害明显加重， 与EF降低的心力衰竭患者相比，心力衰竭患者的虚弱、生活质量和抑郁程度更高。他们似乎也得到了更多的 从干预中受益，在身体功能、虚弱、HRQOL和 抑郁症。HFpEF患者的再住院率似乎也有了更大的下降， 死亡和减少医疗资源使用的可能性。在HFpEF中发现潜在的更大好处是 值得注意的是，HFpEF与老年人高度相关，最迫切需要新的治疗方法 因为它是：1)最常见的心力衰竭形式，几乎是老年人独有的，对老年人的影响不成比例 妇女和黑人；2)患病率增加；3)被认为是老年综合征；4)与 身体机能和HRQOL明显受损，虚弱率高；5)患病率高， 死亡率随着时间的推移正在恶化；以及6)循证治疗有限。第三期戒毒所- HFpEF试验将专注于这一庞大的、不断增长的、脆弱的、服务不足的人口。五年，随机， 注意力控制的单盲试验将招募880名60岁的老年人接受ADHF和HFpEF治疗 分布在20个地理位置分散的临床中心。我们将检验这样一个假设：创新的康复-HF 干预将改善临床上令人信服的全原因再住院的主要终点和 6个月随访期间的死亡率，这是ADHF住院后最脆弱的时期(目标1)和 主要行动能力障碍患病率的次要终点，临床上有意义的结果 6个月大的成年人(目标2)。我们还将评估干预对HRQOL、脆弱、抑郁、 体力活动和医疗保健费用。我们多样化、凝聚力强的多学科团队和来自 第二阶段审判将确保高效率和有效的执行和传播。Rehab-HFpEF直接解决 NIA和NHLBI最近主办的几个研讨会的主要建议。其结果可能会有所改善 对患者、护理人员、卫生系统和付款人有意义的关键结果。审判有很强的针对性 有可能改变临床指南，降低医疗成本，并影响全国覆盖范围 针对大量、不断增长、服务不足、高危的急性HFpEF老年患者的决策。